FDA Device recall Z-0447-2021
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of…
- FDA Device
- Class II
- ongoing
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of… by Shanghai United Imaging Healthcare, citing A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0447-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-05 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Reason
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Identifiers
| code_info | Serial Numbers: 600229, 600230, 600232, 600271, 600282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0447-2021%22
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